Rheumatoid Arthritis Clinical Trial
Official title:
A Phase 1 Dose Escalation Study of Intra-Articular Administration of tgAAC94, a Recombinant Adeno-Associated Vector Containing the TNFR:Fc Fusion Gene, in Inflammatory Arthritis
Study 1304 is a Phase I dose escalation study conducted in adults with persistent moderate
(grade 2) or severe (grade 3) swelling due to inflammatory arthritis (rheumatoid arthritis,
psoriatic arthritis, or ankylosing spondylitis) in at least one peripheral joint eligible
for injection. Disease must not be severe enough to warrant use of a TNF-alpha antagonist in
the next three months.
Current use of TNF-alpha antagonists is not permitted. Subjects with rheumatoid arthritis
must have had an adequate trial of at least one disease-modifying antirheumatic drug (DMARD)
prior to screening.
The primary objective is to evaluate the safety of intra-articular administration of
tgAAC94.
Status | Completed |
Enrollment | 15 |
Est. completion date | November 2005 |
Est. primary completion date | November 2005 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Rheumatoid arthritis, psoriatic arthritis or ankylosing spondylitis, diagnosed according to published criteria - Persistent moderate (grade 2) or sever (grade 3) swelling due to inflammatory arthritis in at least one peripheral joint eligible for injection - For subjects with rheumatoid arthritis, an adequate trial of at least one disease-modifying antirheumatic drug (DMARD) prior to screening - For subjects currently on DMARD(s), a stable regimen for inflammatory arthritis for the previous three months, with no changes in doses in the four weeks prior to screening - Age greater than 18 years - Be willing to practice effective birth control measures during the study, if of reproductive ability - Able to give written informed consent Exclusion Criteria: - Current use of a TNF-alpha antagonist - Disease severe enough to warrant use of a systemic TNF-alpha antagonist in the next three months - Discontinuation of TNF-alpha antagonists in the past because of safety concerns - Current use of anakinra - Poor functional status, defined as being bed-bound or wheelchair-bound - Corticosteriod therapy at doses higher than the equivalent of 10 mg prednisone per day - Any of the following laboratory values: Hemoglobin <8.5 gm/dL, white blood cell count <3500 per mm^3, platelet <100 K/microL, creatinine >2 mg/dL, bilirubin >2 mg/dL, AST or ALT >2 times the upper limit of normal, or abnormal coagulation profiles - Known HIV infection, known hepatitis C infection, or known positive serologic test for hepatitis B surface antigen - Positive PPD, unless previously treated with appropriate prophylaxis - Pregnancy or lactation, either at the time of screening or planned in the next six months - Inflammatory bowel disease, such as Crohn's disease or ulcerative colitis - Serious medical disease, such as sever liver or kidney disease, uncompensated congestive heart failure, myocardial infarction within six months, unstable angina, uncontrolled hypertension, severe pulmonary disease or active asthma, demyelinating neurological disease, history of cancer (other than cutaneous basal and squamous cell carcinoma) with less than five years documentation of a disease free state, insulin-dependent diabetes, recurrent opportunistic infections or other concurrent medical condition that, in the opinion of the investigator, would make the subject unsuitable for the study - Unlikely to comply with the protocol |
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Canada | Mt Sinai Hospital | Toronto | Ontario |
Canada | Toronto Western Hospital | Toronto | Ontario |
Canada | Arthritis Research Centre of Canada | Vancouver | British Columbia |
Canada | Arthritis Centre Clinical Research Unit UofManitoba | Winnipeg | Manitoba |
United States | Denver Arthritis Research Center | Denver | Colorado |
United States | UCLA Division of Rheumatology | Los Angeles | California |
United States | Swedish Rheumoatology Research | Seattle | Washington |
Lead Sponsor | Collaborator |
---|---|
Targeted Genetics Corporation |
United States, Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Serious adverse events | From study drug administration through final study visit | Yes | |
Primary | Severe or very severe adverse events | From study drug administration through final study visit | Yes | |
Primary | Study drug-related adverse events | From study drug administration through final study visit | Yes | |
Secondary | Change in tenderness and swelling of injected joint | Days 3 and 7 and Weeks 2, 4, 8, and 12 | No | |
Secondary | Change in tenderness and swelling of non-injected joints | Weeks 2, 4, and 12 | No | |
Secondary | Reduction in disease activity, as measured by American College of Rheumatology (ACR) criteria and Disease Activity Score (DAS) | Weeks 2, 4, and 12 | No | |
Secondary | Joint fluid measures (cell count and differential, total protein and TNFR:Fc protein) | Weeks 4 and 12 | No | |
Secondary | TNFR:Fc protein levels in serum | Day 7 and Weeks 2, 4, 8, and 12 | No | |
Secondary | Serum neutralizing antibodies to AAV2 | Weeks 4 and 12 | Yes | |
Secondary | Presence of tgAAC94 in peripheral blood mononuclear cells (PBMCs) | Day 3 and Weeks 2 and 8 | Yes |
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